<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">As our company continues we grow we are seeking a <strong>Regulatory and Start Up Specialist </strong>to join our growing team.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Essential functions of the job include but are not limited to:</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.</span></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Interaction with CA/EC for study purposes and handling responses to the CA/EC.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partner with the assigned site CRA to ensure alignment in communication and secure site </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">review and manage collection of essential documents required for site activation/IMP release.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Customize country/site specific Patient Information Sheet and Informed Consent Form. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for/facilitates the translation and co-ordination of translations for documents.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-si